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Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

Primary Purpose

HIV Infections, Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Peginterferon alfa-2a + ribavirin
Sponsored by
Hospital Clinico Universitario San Cecilio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring chronic hepatitis C, co-infection, extend treatment, co-infected HIV-HCV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
  • RNA-HCV positive at 48 week before study and genotype 1 or 4.
  • HIV-1 positive: ELISA y Western-blot.
  • Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
  • Willingness to give written informed consent and willingness to participate to and comply with the study.

Exclusion Criteria:

  • Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
  • Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
  • More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.

Sites / Locations

  • Hospital de Txagorritxu
  • Hospital de Bellvitge
  • Hospital de Jerez
  • Hospital Insular
  • Hospital de Donostia
  • Complejo Hospitalario Universitario
  • Fundación Hospital de Alcorcón
  • Hospital Son Dureta
  • Hospital Santa Creu i Sant Pau
  • Hospital Puerta del Mar
  • Hospital Clínico Universitario San Cecilio
  • Hospital Clínico San Carlos
  • Hospital 12 de Octubre
  • Hospital La Paz
  • Hospital Virgen Macarena
  • Hospital Virgen del Rocío
  • Hospital de Valme
  • Consorcio Hospital General
  • Hospital Clínico de Valladolid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks

Outcomes

Primary Outcome Measures

% of patients with RNA-HCV undetectable

Secondary Outcome Measures

% of percentage of patients with RNA-HCV undetectable

Full Information

First Posted
January 29, 2008
Last Updated
January 29, 2008
Sponsor
Hospital Clinico Universitario San Cecilio
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1. Study Identification

Unique Protocol Identification Number
NCT00612755
Brief Title
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Official Title
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinico Universitario San Cecilio

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients. The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment. In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%. The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment. Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
Detailed Description
To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C
Keywords
chronic hepatitis C, co-infection, extend treatment, co-infected HIV-HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a + ribavirin
Other Intervention Name(s)
Pegasys
Intervention Description
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Primary Outcome Measure Information:
Title
% of patients with RNA-HCV undetectable
Time Frame
at 48 week of study (24 weeks after the end of treatment period of trial).
Secondary Outcome Measure Information:
Title
% of percentage of patients with RNA-HCV undetectable
Time Frame
24 weeks of trial period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week RNA-HCV positive at 48 week before study and genotype 1 or 4. HIV-1 positive: ELISA y Western-blot. Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study). Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. Willingness to give written informed consent and willingness to participate to and comply with the study. Exclusion Criteria: Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day). Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described. More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Hernández-Quero, Dr
Organizational Affiliation
Hospital Clínico Universitario San Cecilio
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Txagorritxu
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Insular
City
Las Palmas
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastián
State/Province
Guipúzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario
City
Santiago
State/Province
La Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Fundación Hospital de Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Clínico Universitario San Cecilio
City
Granada
ZIP/Postal Code
18013
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41008
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Consorcio Hospital General
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Clínico de Valladolid
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

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Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

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